The Effect of the Modified Mitchell Relaxation Method on Acute Cardiac Autonomic Modulation
16 de julio de 2026 actualizado por: Utku Berberoğlu, Balikesir University
The purpose of this multi-center, randomized controlled trial is to investigate the acute effects of the standard Laura Mitchell Physiological Relaxation Method versus a Modified Mitchell Relaxation Version on cardiac autonomic modulation (heart rate variability).
The study will include 122 participants aged 18-65 who score 10 or higher on the Generalized Anxiety Disorder-7 (GAD-7) scale, indicating high anxiety and potentially reduced parasympathetic control.
Participants will be randomly allocated into two equal groups (n=61 per group) using a block randomization system with a concealed envelope method.
To control for expectation bias, an incomplete disclosure protocol will be utilized, ensuring participants remain blinded to their specific group allocation.
Both interventions will last 35 minutes and will be delivered via audio recordings in a supine position (Mitchell's 'Position A') to prevent investigator bias.
Cardiac autonomic responses will be assessed using a Polar H10 chest strap to analyze Heart Rate Variability (HRV) before, during, and after the sessions.
Blood pressure and respiration rate will also be monitored as secondary outcomes
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
122
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Utku Berberoğlu, Assistant Professor
- Número de teléfono: +905052017066
- Correo electrónico: utku.berberoglu@balikesir.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Dilek Işık, MsC
- Número de teléfono: +905372569963
- Correo electrónico: caldilek10@gmail.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Being 18-65 years old.
- Having stress and anxiety
Exclusion Criteria:
- Taking cardioactive/psychotropic drugs.
- Having a diagnosis of cardiovascular disease.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Standard Laura Mitchell Exercises
|
Original Relaxation Exercises based on Skin and Proprioceptive Awareness and Reciprocal Mussle Inhibition
Otros nombres:
|
|
Experimental: Modified Mitchell Exercises
|
Modified Relaxation Exercises based on Muscle Energy Technique, Deep Breathing, Additional Natural Relxation Postures in addition Skin and Proprioceptive Awareness and Reciprocal Mussle .
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
RMSSD - Root Mean Square of Succesive Differences of RR Peaks of EKG
Periodo de tiempo: During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
Root Mean Square of Succesive Differences of RR Peaks of EKG
|
During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time-Domain Heart Rate Variability Parameters (SDNN, RMSSD, Mean RR Interval)
Periodo de tiempo: During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
Time-domain HRV parameters, including the standard deviation of NN intervals (SDNN), the root mean square of successive differences between normal heartbeats (RMSSD), and mean RR interval duration, will be calculated from continuous ECG/PPG recordings.
[Unit: milliseconds]
|
During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
|
Absolute Spectral Power HRV Parameters (LF, HF)
Periodo de tiempo: During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
Low-frequency (LF, 0.04-0.15
Hz) and high-frequency (HF, 0.15-0.4
Hz) spectral power components of heart rate variability will be calculated from RR interval series using power spectral density analysis.
[Unit: ms²]
|
During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
|
LF/HF Ratio
Periodo de tiempo: During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
The ratio of low-frequency to high-frequency spectral power, reflecting sympathovagal balance, will be calculated from RR interval series.
[Unit: ratio (unitless)]
|
During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
|
Poincaré Plot HRV Parameters (SD1, SD2)
Periodo de tiempo: During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
Standard deviation of the Poincaré plot perpendicular to the line of identity (SD1) and along the line of identity (SD2), reflecting short- and long-term heart rate variability, will be calculated from RR interval series.
[Unit: milliseconds]
|
During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
|
Non-linear HRV Complexity Parameters (SD1/SD2 Ratio, Sample Entropy)
Periodo de tiempo: During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
The SD1/SD2 ratio and sample entropy (SampEn), reflecting the complexity and unpredictability of heart rate dynamics, will be calculated from RR interval series.
[Unit: unitless]
|
During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de julio de 2028
Finalización del estudio (Estimado)
1 de julio de 2028
Fechas de registro del estudio
Enviado por primera vez
26 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de julio de 2026
Publicado por primera vez (Actual)
20 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GO 2026/125
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All de-identified individual participant data collected during the trial will be made available indefinitely in a publicly accessible data repository immediately following the publication of the study results.
Marco de tiempo para compartir IPD
Upon publication and indefinitely.
Criterios de acceso compartido de IPD
Data will be made publicly available in an open-access repository immediately after publication.
There are no restrictions on access, and no formal application or approval is required to download the de-identified dataset.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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